Infusion device capable of providing multiple liquid medicaments

ABSTRACT

A disposable infusion device comprises a base arranged to adhere to a patient&#39;s skin and a cannula arranged to extend from the base to beneath the patient&#39;s skin to deliver a liquid medicament to the patient. The device further includes a first source arranged to provide the cannula with a first liquid medicament and a second source arranged to provide the cannula with a second liquid medicament.

CLAIM OF PRIORITY

This application claims priority to U.S. Provisional Application Ser.No. 60/782,941, filed on Mar. 16, 2006, which is incorporated byreference.

BACKGROUND

Tight control over the delivery of insulin in both type I (usuallyjuvenile onset) and type II (usually late adult onset), has been shownto improve the quality of life as well as the general health of thesepatients. Insulin delivery has been dominated by subcutaneous injectionsof both long acting insulin to cover the basal needs of the patient andby short acting insulin to compensate for meals and snacks. Recently,the development of electronic, external insulin infusion pumps hasallowed the continuous infusion of fast acting insulin for themaintenance of the basal needs as well as the compensatory doses formeals and snacks. These infusion systems have shown to improve controlof blood glucose levels, however, they suffer the drawbacks of size,cost, and complexity, which prevents many patients from accepting thistechnology over the standard subcutaneous injections. These pumps areelectronically controlled and must be programmed to supply the desiredamounts of basal and bolus insulin.

SUMMARY

In one embodiment the invention provides a disposable infusion devicecomprising a base arranged to adhere to a patient's skin, a cannulaarranged to extend from the base to beneath the patient's skin todeliver a liquid medicament to the patient, a first source arranged toprovide the cannula with a first liquid medicament, and a second sourcearranged to provide the cannula with a second liquid medicament.

One of the first and second sources may be arranged to provide itsliquid medicament in fixed volume increments. The one of the first andsecond sources may include a reservoir for holding the liquid medicamentand a fixed volume pump that delivers the liquid medicament to thecannula in the fixed volume increments. The fixed volume pump maycomprise a piston pump, a dome pump, or a squeezable tube.

One of the first and second sources may comprise a reservoir. Forexample, the first source may comprise a reservoir and a pump and thesecond source may include a port. The port may be arranged tocommunicate with the cannula and to receive the second liquid medicamentfrom an instrument external to the device.

The one of the first and second sources may include a pump communicatingwith the reservoir and arranged to deliver the liquid medicament to thecannula and a mechanical motor that drives the pump. The mechanicalmotor may include a wind-up spring.

The one of the first and second sources may include a pump and a fillport communicating with the reservoir to enable the reservoir to befilled by an instrument external to the device. The reservoir may beformed of flexible material.

In another embodiment, the first source may comprise a first reservoir,the second source may comprise a second reservoir, and the device mayfurther include a valve that selectively communicates the firstreservoir with the cannula or the second reservoir with the cannula.

In a further embodiment, the first source may comprise a first reservoirarranged to hold the first liquid medicament and a first pump arrangedto deliver the first liquid medicament to the cannula and the secondsource may comprise a second reservoir arranged to hold the secondliquid medicament and a second pump arranged to deliver the secondliquid medicament to the cannula. One of the first and second sources isarranged to provide its associated liquid medicament at a substantiallyconstant rate. The device may further comprise a rate adjuster thatrenders the substantially constant rate adjustable.

One of the first and second sources may be a replaceable reservoir.

In a still further embodiment, a disposable infusion device comprises abase arranged to adhere to a patient's skin, a cannula arranged toextend from the base to beneath the patient's skin to deliver a liquidmedicament to the patient, a first source arranged to provide thecannula with a first liquid medicament, and a second source arranged toprovide the cannula with a second liquid medicament. The first sourceincludes a reservoir and a pump that pumps the first liquid medicamentfrom the reservoir to the cannula, and the second source includes a portthat receives the second liquid medicament from an instrument externalto the device and conveys the second liquid medicament to the cannula.

The pump may comprise a fixed volume pump that delivers the liquidmedicament to the cannula in fixed volume increments.

The fixed volume pump may comprise a piston pump, a dome pump, or asqueezable tube.

In a still further embodiment, a disposable infusion device comprises abase arranged to adhere to a patient's skin, a cannula arranged toextend from the base to beneath the patient's skin to deliver a liquidmedicament to the patient, a first source arranged to provide thecannula with a first liquid medicament, and a second source arranged toprovide the cannula with a second liquid medicament. The first source isa first reservoir that holds the first liquid medicament and the secondsource is a second reservoir that holds the second liquid medicament.The device further includes a pump that pumps the first and/or secondliquid to the cannula. The pump may be a single pump communicating withthe cannula and the device may further include a valve that selectivelycouples the first and second reservoirs to the pump. The pump maycomprise a first pump that pumps the first liquid medicament from thefirst reservoir to the cannula and a second pump that pumps the secondliquid medicament from the second reservoir to the cannula, and thedevice may further include a valve that selectively couples the firstpump and the second pump to the cannula.

BRIEF DESCRIPTION OF THE DRAWINGS

The features of the present invention which are believed to be novel areset forth with particularity in the appended claims. The invention,together with further features and advantages thereof, may best beunderstood by making reference to the following description taken inconjunction with the accompanying drawings, in the several figures ofwhich like reference numerals identify identical elements, and wherein:

FIG. 1 is a side view of an infusion port that may be used in practicingthe invention;

FIG. 2 is a side view of an infusion port, loading membrane, and insulinreservoir according to one embodiment of the invention;

FIG. 2A is a schematic diagram illustrating one potential manner ofoperation of the system of FIG. 2;

FIG. 2B a schematic diagram illustrating another potential manner ofoperation of the system of FIG. 2;

FIG. 3 is a side view, with portions cut away, of a disposable insulininfusion system including a mechanical timer according to anotherembodiment of the invention;

FIG. 4 is a perspective view of a disposable insulin infusion systemthat provides for both basal delivery and bolus delivery of insulinaccording to an embodiment of the invention;

FIG. 4A is a side view, with portions cut away, showing more particularsof the operation of the system of FIG. 4;

FIG. 5 is a perspective view of a disposable insulin infusion systemproviding user basal delivery rate adjustment and bolus delivery ofinsulin;

FIG. 6 is a side view of a disposable insulin infusion system includingconstant insulin delivery device and a separate mating bolus deliverydevice according to an embodiment of the invention;

FIG. 7 is a top view, with portions cut away, of an insulin infusionsystem according to another embodiment of the invention having insulindelivery rate determined by a chamber pressure;

FIG. 7A is a schematic diagram illustrating one potential manner ofoperation of the system of FIG. 7;

FIG. 8 is a side view of an insulin infusion system having insulin bolusdelivery volume controlled by peristaltic action according to anembodiment of the invention;

FIG. 9 is an end view of the system of FIG. 8;

FIG. 10 is a schematic diagram of a further system embodying theinvention;

FIG. 11 is a side view, with portions cut away, of a bolus pumpembodying the invention prior to insulin delivery; and

FIG. 12 is a side view, with portions cut away, of the bolus pump ofFIG. 11 embodying the invention after insulin delivery.

DETAILED DESCRIPTION

FIG. 1 shows an infusion port 10 into which a liquid medicament, such asinsulin or incretins, can be injected manually using a standard syringe.The port 10 includes a funnel port 12, an insertion needle 14, and aninjection membrane 16. The port 10 may be adhered to the skin 18 withadhesive tape 20. This system obviates the need for multiple dailypercutaneous needle sticks to accomplish the provision of insulindosage.

The port 10 further includes a cannula 15. The cannula 15 is carried bythe funnel port 12. As known in the art, once the needle 14 and cannula15 are positioned beneath the skin 18 as shown, the needle 14 is removedleaving the cannula 15 in a deployed position and ready to deliverinsulin to the patient.

FIG. 2 shows a system 30 according to one embodiment of the invention.The system includes an infusion port 32 similar to port 10 for deliveryof either long acting or short acting insulin. The port 32 is shownprior to the needle 39 being withdrawn from the cannula 41. The systemincludes a first source 31 including a reservoir 34 which may be filledwith a fast acting insulin through a port 36 and a pump 38. A furtherreservoir may be provided as will be seen subsequently. The port allowsfor reservoir 34 to internally hold a first liquid medicament, such as afast acting insulin, for delivery at meals, for example, while thefunnel port 33 of the port 32 forms a second source 43 and allows for asecond liquid medicament, such as a slow acting insulin to be deliveredas, for example, in the morning after awakening. The fast acting insulinmay be delivered by the pump 38 which may be squeezed with the fingers.

In the case when the system 30 includes multiple reservoirs, the systemmay have a mechanism for the selection of which insulin is infused atany given time. It also may provide control over how much of eachparticular insulin is determined to be delivered by having the patientdepress the actuator 38 a desired number of times. For example, eachactivation might deliver 0.5 units of insulin. Therefore, if 3 units ofinsulin are desired, 6 depressions will deliver the desired amount.

FIG. 2A shows one manner of operation of the system 30. Fast actinginsulin may be loaded into reservoir 34 through loading port 36. Thepump 38 may be a piston pump and more particularly, a fixed strokepiston pump which provides a predetermined volume of insulin upon eachactuation. The number of depressions of pump 38 thus determines theamount of the fast acting insulin delivered from reservoir 34 to port 32and cannula 41. When a slow acting insulin is to be delivered, such asin the morning upon awakening, the slow acting insulin may be deliveredthrough funnel port 33. In that regard, it will be noted that the port33 permits the slow acting insulin to be received from an instrument,such as syringe 39, from external to the system 30. It may further benoted that the infusion system 30 further includes one-way valves 45 and47. Valve 45 is between the pump 38 and reservoir 34 and valve 47 isbetween port 32 and pump 38.

FIG. 2B shows another manner in which the system 30 may operate. Here,in addition to the reservoir 34 for the fast acting insulin, the systemincludes another reservoir 35 to contain slow acting insulin. The fastacting insulin is loaded into reservoir 34 through port 36. The slowacting insulin may be loaded into the reservoir 35 through port 37. Avalve 40 controls which reservoir is selected as well as the rate inwhich the selected insulin is delivered. The pump 38, which again may bea fixed stroke piston pump, is used for pumping the selected insulin outto the patient through port 32. Valves 45 and 47 remain on oppositesides of the pump 38.

FIG. 3 shows a system 50 for the constant delivery of a fixed amount ofinsulin per unit time. The insulin delivered over time is fast actinginsulin, to meet the basal needs. This insulin is contained in areservoir 52. An adjunctive port 54 for the injection of fast actinginsulin for meals and snacks is also provided.

The insulin in reservoir 52 is constantly delivered under the control ofa mechanical timer pump 56. The timer pump is of the type known in theart to include a winder 58, a wind-up spring 60, and gears 62. The gears62 drive a worn gear 63 and lead screw 65 to drive a piston 67. Thepiston 67 thus pressurizes the reservoir 52 to provide a constant flowof insulin to the cannula 66. When a bolus of fast acting insulin isrequired, such as at meals, the port 54 is used to inject the fastacting insulin into the reservoir 52. When the reservoir is full,further injected insulin will displace a like quantity of insulin fromreservoir 52 thereby injecting the same into and out of the cannula 66.

FIG. 4 shows a device embodiment 70 with an infusion port for thedelivery of a fixed amount of fast acting insulin per unit time plus themechanisms for delivery of boluses for meals and snacks. A slide 72 isprovided to pressurize the insulin chamber (not shown). A fillingmembrane 74 permits the chamber to be filled. A trigger 76 may bedepressed for each measured bolus of insulin to be delivered.

Referring now to FIG. 4A, here it may be seen that the slide 72 performsan additional function after the patient has deployed the cannula 73.More specifically, the needle 71 may be retracted from the cannula 73 toleave the cannula 73 in a fully deployed position for delivering insulinto the patient. To this end, the slide 72 is coupled to the deviceneedle 71 housed in the infusion tube 73. As the slide is slid back inthe direction of the arrow 75, the needle 71 is retracted. Eventually,the needle is captured by a needle capture chamber 77. Further backwardmovement of slide 72 eventually causes the needle head 71 a to be caughtby a needle ejector 79. Upon further backward movement of slide 72, theneedle ejector 79 is acted upon by a ramp 81 that causes the needle headto be displaced in the direction of arrow 79 a. Such needle headdisplacement forces the needle off of the slide 72. At this point, theneedle is dropped within the device 70 and cannot be reused. The deviceis now safe and ready for disposal after it has been fully used.

FIG. 5 shows a similar device 80 having a dial for the delivery of auser adjusted variable amount of fast acting insulin per unit time. Thisembodiment is particularly helpful for patients who may need a differentamount of basal insulin support at different times during the day. Thedevice 80 further includes mechanisms including a wind-up 84 and trigger86 for delivery of boluses for meals and snacks. A filling membrane 88is provided to facilitate filling of the insulin reservoir (not shown)with the fast acting insulin.

FIG. 6 shows an embodiment of infusion port 90 with an internalreservoir 92 to hold fast acting insulin for constant delivery of afixed amount per unit time to meet the basal needs of the patient withan adjunctive bolus module 94 to provide separate bolus delivery. Themodule 94 is mated to the internal reservoir for the needs of meals andsnacks. The module 94 may contain enough insulin to last considerablylonger than the insulin contained in the reservoir 92. When reservoir 92is exhausted, the module 94 may simply be mated with another reservoirlike that of reservoir 92. Both the constantly fed insulin and theboluses may be delivered through the infusion tube 96. The device may beadhered to the skin with adhesive tape 98.

FIG. 7 shows a disposable insulin infusion device 100 for delivery of aconstant flow of insulin utilizing a substantially constant pressuresource and a small, flow control orifice. More specifically, the device100 includes a reservoir 101 including a chamber 102 for containing afast acting insulin. A wall 104 of the chamber 102 includes a smallorifice 106. Another wall 109 of the chamber 102 is moveable under theinfluence of a spring 110 within an expanding chamber 112. Thispressurizes the reservoir 102 to control the flow of insulin through theorifice 106 and into the infusion tube or cannula 108. Hence, the device100 of FIG. 7 is similar to the device of FIG. 3 in that a reservoir ofinsulin is pressurized to deliver a constant flow of insulin to acannula.

FIG. 7A is a schematic representation of the operation of another device115 similar to the device 100 of FIG. 7. Here it may be seen that theinsulin is pressurized by gas within the pressurized reservoir 102. Theorifice 106 restricts the flow of insulin by a controlled amount to theinfusion tube or cannula 108. In addition, the device 115 includes abolus pump 114 to pump boluses of fast acting insulin from anotherreservoir (or the same reservoir) to the infusion tube or cannula 108.Again, the pump 114 may be a fixed stroke piston pump. Also, one-wayvalves 45 and 47 are positioned on opposite sides of the pump 114 as inprevious embodiments.

FIGS. 8 and 9 show another disposable insulin infusion device 120embodying the invention. Here, a volume adjustment mechanism is providedto control the volume of insulin delivered with each actuation. Thisactuation may be manual to adjust boluses for meals and snacks or atspecific timed intervals for an adjustable effective basal rate.

More specifically, the device 120 includes a reservoir 122 forcontaining a fast acting insulin. The device further includes disk 124having a groove 126 that increases in depth along the circumference ofthe disk 124. A flexible tube 130 extends from the reservoir 122 aroundthe disk 124 and within the groove 126. A strap 132 extends from a fixedtie point 134 along the tube 130 to an actuator 136. As the disk isrotated in the clockwise direction, an increasing length of the tube 130will reside in the groove 126. Conversely, counter-clockwise rotation ofdisk 124 will cause a decreased length of the tube 130 to reside in thegroove 126. When the actuator 136 is moved in the direction of arrow138, the strap 132 acts upon (compresses) the portion of the tube 130not in the groove 126 to cause a measured bolus of insulin to bedelivered to the infusion tube 140. Hence, as more tubing is acted uponby the strap 132, a larger volume bolus is delivered by peristalticaction. The disk 124 may be rotated by a dial, such as the dial 82 ofthe device 86 of FIG. 5.

FIG. 10 schematically illustrates the operation of another disposableinsulin infusion device 150 embodying the invention. Here there areseparate reservoirs 152 and 154 for fast acting insulin and slow actinginsulin respectively. Each reservoir is associated with its ownrespective pump. Reservoir 152 is associated with pump 156 and reservoir154 is associated with pump 158. The pumps 156 and 158 may be fixedstroke piston pumps as shown. The reservoirs 152 and 154 deliver underthe pumping action of pumps 156 and 158 their respective insulin to acommon port 160 coupled to a cannula 162. Again, one-way valves 145 and147 are on opposite sides of pump 156, and one-way valves 141 and 143are on opposite sides of pump 158.

FIGS. 11 and 12 show a bolus pump 170 embodying the invention. The pump170 takes the form of a dome pump as illustrated. FIG. 11 shows the pump170 prior to being depressed by the patient's finger 172 and FIG. 12shows the pump after being depressed and insulin delivery. The pump 170may be arranged to deliver 0.5 units of insulin with each actuation andprovide tactile feedback with each actuation of the pump.

As may be noted, the pump includes a resilient membrane 174 sealed to abase 176 by a sealing ring 178. The base may be adhered to the patient'sskin by adhesive tape (not shown). The pump 170 also includes an intakevalve 180 which permits insulin to enter the inner cavity 184 formed bythe membrane 174 and base 176 when the membrane returns to theconfiguration shown in FIG. 11. An output valve 182 permits insulin toflow from the cavity 184 when the membrane is depressed as shown in FIG.12. The inner cavity may be arranged to displace a volume of 0.5 unitsof insulin for each depression of the pump 170. Hence, if 3 units ofinsulin are required for a meal, for example, the pump 170 may bedepressed 6 times to deliver the desired amount of insulin to thepatient.

While particular embodiments of the present invention have been shownand described, modifications may be made, and it is therefore intendedin the appended claims to cover all such changes and modifications whichfall within the true spirit and scope of the invention as defined bythose claims.

1. A disposable infusion device comprising: a base arranged to adhere toa patient's skin; a cannula arranged to extend from the base to beneaththe patient's skin to deliver a liquid medicament to the patient; afirst source arranged to provide the cannula with a first liquidmedicament; and a second source arranged to provide the cannula with asecond liquid medicament.
 2. The device of claim 1, wherein one of thefirst and second sources is arranged to provide its liquid medicament infixed volume increments.
 3. The device of claim 2, wherein the one ofthe first and second sources includes a reservoir for holding the liquidmedicament and a fixed volume pump that delivers the liquid medicamentto the cannula in the fixed volume increments.
 4. The device of claim 3,wherein the fixed volume pump comprises a piston pump.
 5. The device ofclaim 3, wherein the fixed volume pump comprises a dome pump.
 6. Thedevice of claim 3, wherein the fixed volume pump comprises a squeezabletube.
 7. The device of claim 1, wherein one of the first and secondsources comprises a reservoir.
 8. The device of claim 7, wherein thefirst source comprises a reservoir and a pump and wherein the secondsource includes a port.
 9. The device of claim 8, wherein the port isarranged to communicate with the cannula and to receive the secondliquid medicament from an instrument external to the device.
 10. Thedevice of claim 7 wherein the one of the first and second sourcesincludes a pump communicating with the reservoir and arranged to deliverthe liquid medicament to the cannula and a mechanical motor that drivesthe pump.
 11. The device of claim 10, wherein the motor includes awind-up spring.
 12. The device of claim 7 wherein the one of the firstand second sources includes a pump and a fill port communicating withthe reservoir to enable the reservoir to be filled by an instrumentexternal to the device.
 13. The device of claim 7, wherein the reservoiris formed of flexible material.
 14. The device of claim 1, wherein thefirst source comprises a first reservoir, wherein the second sourcecomprises a second reservoir, and wherein the device further includes avalve that selectively communicates the first reservoir with the cannulaor the second reservoir with the cannula.
 15. The device of claim 1,wherein the first source comprises a first reservoir arranged to holdthe first liquid medicament and a first pump arranged to deliver thefirst liquid medicament to the cannula, and wherein the second sourcecomprises a second reservoir arranged to hold the second liquidmedicament and a second pump arranged to deliver the second liquidmedicament to the cannula.
 16. The device of claim 1, wherein one of thefirst and second sources is arranged to provide its associated liquidmedicament at a substantially constant rate.
 17. The device of claim 16,further comprising a rate adjuster that renders the substantiallyconstant rate adjustable.
 18. The device of claim 1, wherein one of thefirst and second sources includes a replaceable reservoir.
 19. Adisposable infusion device comprising: a base arranged to adhere to apatient's skin; a cannula arranged to extend from the base to beneaththe patient's skin to deliver a liquid medicament to the patient; afirst source arranged to provide the cannula with a first liquidmedicament; and a second source arranged to provide the cannula with asecond liquid medicament, wherein the first source is a reservoir and apump that pumps the first liquid medicament from the reservoir to thecannula, and wherein the second source is a port that receives thesecond liquid medicament form an instrument external to the device andconveys the second liquid medicament to the cannula.
 20. The device ofclaim 19, wherein the pump is a fixed volume pump that delivers theliquid medicament to the cannula in fixed volume increments.
 21. Thedevice of claim 20, wherein the fixed volume pump comprises a pistonpump.
 22. The device of claim 20, wherein the fixed volume pumpcomprises a dome pump.
 23. The device of claim 20, wherein the fixedvolume pump comprises a squeezable tube.
 24. A disposable infusiondevice comprising: a base arranged to adhere to a patient's skin; acannula arranged to extend from the base to beneath the patient's skinto deliver a liquid medicament to the patient; a first source arrangedto provide the cannula with a first liquid medicament; a second sourcearranged to provide the cannula with a second liquid medicament, whereinthe first source is a first reservoir that holds the first liquidmedicament, wherein the second source is a second reservoir that holdsthe second liquid medicament; and a pump that pumps the first and/orsecond liquid to the cannula.
 25. The device of claim 24, wherein thepump is a single pump communicating with the cannula and wherein thedevice further includes a valve that selectively couple the first andsecond reservoirs to the pump.
 26. The device of claim 24, wherein thepump comprises a first pump that pumps the first liquid medicament fromthe first reservoir to the cannula and a second pump that pumps thesecond liquid medicament from the second reservoir to the cannula, andwherein the device further includes a valve that selectively couples thefirst pump and the second pump to the cannula.